# Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

> **NIH NIH R01** · WASHINGTON UNIVERSITY · 2022 · $3,021,234

## Abstract

Hip fractures are common among older women and can have a devastating impact on their ability to
remain independent. A clinically important functional decline and failure to recover following a hip fracture has
been documented as much as a year after the fracture, even among individuals who were functioning at high
levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass,
strength and power that are common in this patient population before the fracture, and are exacerbated
afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has
demonstrated the feasibility of T treatment in this population, and showed gains in lean body mass (LBM) and
muscle strength with active drug, compared to placebo. The benefits of exercise in restoring muscle strength
and physical function after a hip fracture have been documented. However, it remains unclear whether T
treatment can augment the effects of exercise on mobility and patient-reported function, or whether any
observed benefits are sustained beyond the period of active treatment. Proposed is a 3-group, multi-center,
randomized, placebo-controlled, double-blinded, parallel group clinical trial in frail elderly female hip fracture
patients. 300 female hip fracture patients will be enrolled from 6 clinical sites, using objective screening criteria
for T deficiency (serum total testosterone level < 30 ng/dl) and physical frailty (Modified Physical Performance
Test (PPT) Score < 28). The trial will compare the effects of supervised exercise training (EX) alone, EX
combined with T therapy (EX+T) and no EX with placebo T treatment (CON), to ascertain the incremental
impact of adding T to ET in older adult women following hip fracture. The 6-month intervention will be followed
by a 6-month no-treatment sustainability phase. The primary outcome measure is the Six Minute Walk
Distance (6MWD). Secondary outcome measures include: 1) dual energy x-ray absorptiometry (DXA)
measurements of whole body and appendicular LBM and bone mineral density of the unfractured proximal
femur; 2) maximal skeletal muscle strength (1-RM) for leg extension in both limbs; 3) objective physical
performance measures; and 4) self-reported performance of activities of daily living and quality of life, including
the Hip Rating Questionnaire (HRQ). We plan to carefully monitor testosterone levels, adverse events,
biochemical parameters, and factors related to adherence to the interventions.
 Information from this study has the potential to alter treatment of hip fracture in older women, a problem
that contributes to significant morbidity and mortality, and has a large public health impact. The proposed
study is highly aligned with NIA’s mission of identifying interventions that target common geriatric conditions,
and improve treatment options for older adults with multiple morbidities or risk factors.

## Key facts

- **NIH application ID:** 9953942
- **Project number:** 5R01AG051647-04
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** ELLEN F BINDER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $3,021,234
- **Award type:** 5
- **Project period:** 2017-09-15 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9953942

## Citation

> US National Institutes of Health, RePORTER application 9953942, Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture (5R01AG051647-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9953942. Licensed CC0.

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